Human Genome Sciences and Lonza agreedt for the future commercial supply of BENLYSTA® (belimumab), which is currently under regulatory review in the United States and Europe as a potential new treatment for systemic lupus erythematosus (SLE)
ROCKVILLE, MD, USA & BASEL, Switzerland | July 13, 2010 | Human Genome Sciences, Inc. (Nasdaq:HGSI – News) and Lonza today announced an agreement for the future commercial supply of BENLYSTA® (belimumab), which is currently under regulatory review in the United States and Europe as a potential new treatment for systemic lupus erythematosus (SLE). BENLYSTA is being developed by HGS and GlaxoSmithKline (GSK) under a co-development and commercialization agreement entered into in 2006.
“Our HGS large-scale manufacturing facility has ample capacity to provide worldwide supply of BENLYSTA following approval, and for the first two or three years following launch,” said Randy J. Maddux, Vice President, Manufacturing Operations, HGS. “However, we believe that we will eventually require additional capacity. After a careful review of proposals from a number of highly qualified commercial manufacturing organizations, we have selected Lonza, a leader in biologics manufacturing with a global network of large-scale production sites. We are confident that Lonza is the right choice to fill this critically important role.”
In June 2010, GSK submitted a Marketing Authorization Application to the European Medicines Agency, seeking approval to market belimumab in Europe for treatment of autoantibody-positive patients with SLE, and HGS submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration seeking approval to market belimumab in the United States. No new drug for lupus has been approved by regulatory authorities in more than 50 years.
“We are enthusiastic about supporting the future production of BENLYSTA with our cutting-edge capabilities and expertise in biopharmaceutical manufacturing,” said Dr. Stephan Kutzer, Chief Operating Officer, Lonza Custom Manufacturing. “Working on such an important new drug for lupus patients will be very rewarding and the basis for a long-term, collaborative relationship with HGS.”
About BENLYSTA (belimumab)
Belimumab is an investigational human monoclonal antibody drug that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS. BLyS is a naturally occurring protein discovered by HGS that is required for the development of B-lymphocyte cells into mature plasma B cells. Plasma B cells produce antibodies, the body’s first line of defense against infection. In lupus and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies – antibodies that attack and destroy the body’s own healthy tissues. The presence of autoantibodies appears to correlate with disease severity. Preclinical and clinical studies demonstrated that belimumab reduced autoantibody levels in SLE. The results of two pivotal Phase 3 trials, BLISS-52 and BLISS-76, demonstrated that belimumab reduced SLE disease activity.
About Lonza
Lonza is one of the world’s leading suppliers to the pharmaceutical, healthcare and life science industries. Its products and services span its customers’ needs from research to final product manufacture. Lonza is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Lonza is also a leading provider of value chemical and biotech ingredients to the nutrition, hygiene, preservation, agro and personal care markets. Lonza is headquartered in Basel, Switzerland and is listed on the SIX Swiss Exchange. In 2009, Lonza had sales of CHF 2.690 billion. Further information can be found at www.lonza.com.
About Human Genome Sciences
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs.
For more information about HGS, please visit the Company’s web site at www.hgsi.com. Health professionals and patients interested in clinical trials of HGS products may inquire via e-mail to medinfo@hgsi.com or by calling HGS at (877) 822-8472.
HGS, Human Genome Sciences and BENLYSTA are trademarks of Human Genome Sciences, Inc. Other trademarks referenced are the property of their respective owners.
SOURCE: Human Genome Sciences (HGS)
Post Views: 37
Human Genome Sciences and Lonza agreedt for the future commercial supply of BENLYSTA® (belimumab), which is currently under regulatory review in the United States and Europe as a potential new treatment for systemic lupus erythematosus (SLE)
ROCKVILLE, MD, USA & BASEL, Switzerland | July 13, 2010 | Human Genome Sciences, Inc. (Nasdaq:HGSI – News) and Lonza today announced an agreement for the future commercial supply of BENLYSTA® (belimumab), which is currently under regulatory review in the United States and Europe as a potential new treatment for systemic lupus erythematosus (SLE). BENLYSTA is being developed by HGS and GlaxoSmithKline (GSK) under a co-development and commercialization agreement entered into in 2006.
“Our HGS large-scale manufacturing facility has ample capacity to provide worldwide supply of BENLYSTA following approval, and for the first two or three years following launch,” said Randy J. Maddux, Vice President, Manufacturing Operations, HGS. “However, we believe that we will eventually require additional capacity. After a careful review of proposals from a number of highly qualified commercial manufacturing organizations, we have selected Lonza, a leader in biologics manufacturing with a global network of large-scale production sites. We are confident that Lonza is the right choice to fill this critically important role.”
In June 2010, GSK submitted a Marketing Authorization Application to the European Medicines Agency, seeking approval to market belimumab in Europe for treatment of autoantibody-positive patients with SLE, and HGS submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration seeking approval to market belimumab in the United States. No new drug for lupus has been approved by regulatory authorities in more than 50 years.
“We are enthusiastic about supporting the future production of BENLYSTA with our cutting-edge capabilities and expertise in biopharmaceutical manufacturing,” said Dr. Stephan Kutzer, Chief Operating Officer, Lonza Custom Manufacturing. “Working on such an important new drug for lupus patients will be very rewarding and the basis for a long-term, collaborative relationship with HGS.”
About BENLYSTA (belimumab)
Belimumab is an investigational human monoclonal antibody drug that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS. BLyS is a naturally occurring protein discovered by HGS that is required for the development of B-lymphocyte cells into mature plasma B cells. Plasma B cells produce antibodies, the body’s first line of defense against infection. In lupus and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies – antibodies that attack and destroy the body’s own healthy tissues. The presence of autoantibodies appears to correlate with disease severity. Preclinical and clinical studies demonstrated that belimumab reduced autoantibody levels in SLE. The results of two pivotal Phase 3 trials, BLISS-52 and BLISS-76, demonstrated that belimumab reduced SLE disease activity.
About Lonza
Lonza is one of the world’s leading suppliers to the pharmaceutical, healthcare and life science industries. Its products and services span its customers’ needs from research to final product manufacture. Lonza is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Lonza is also a leading provider of value chemical and biotech ingredients to the nutrition, hygiene, preservation, agro and personal care markets. Lonza is headquartered in Basel, Switzerland and is listed on the SIX Swiss Exchange. In 2009, Lonza had sales of CHF 2.690 billion. Further information can be found at www.lonza.com.
About Human Genome Sciences
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs.
For more information about HGS, please visit the Company’s web site at www.hgsi.com. Health professionals and patients interested in clinical trials of HGS products may inquire via e-mail to medinfo@hgsi.com or by calling HGS at (877) 822-8472.
HGS, Human Genome Sciences and BENLYSTA are trademarks of Human Genome Sciences, Inc. Other trademarks referenced are the property of their respective owners.
SOURCE: Human Genome Sciences (HGS)
Post Views: 37
